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Keeping Limits on Medical Resident Work Hours Is the Right Thing to do, but the Unethical FIRST Trial Must End

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: On Tuesday, The Accreditation Council for Graduate Medical Education (ACGME), which oversees residency training programs at teaching hospitals and universities, released a letter (PDF) saying it will not modify the caps on work hours of doctors in training for the upcoming academic year, but would allow the continuation of an unethical clinical trial involving general surgery residents and their patients.

We are relieved to hear that the ACGME will not be loosening restrictions on medical resident work hours for the upcoming academic year. We strongly oppose any such action, now or in the future, because a substantial body of evidence demonstrates that sleep deprivation caused by resident shifts lasting 24 or more hours threatens the health and welfare of both residents and their patients.

However, we are disturbed to learn that the ACGME is extending the waiver of some of the organization’s current key work hour restrictions and providing funding to allow the continuation of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial for a third year. Public Citizen and the American Medical Student Association previously explained to the ACGME that the FIRST trial is highly unethical and fails to comply with federal regulations for the protection of human research subjects.

The ACGME’s decision to facilitate continuation of this unethical trial, which exposes hundreds of first-year general surgery residents to well-documented increased risk of serious harm − including risks of motor vehicle accidents, needle-stick injuries, exposure to blood-borne pathogens and depression − without the residents’ voluntary informed consent and without appropriate ethics review by institutional review boards represents a serious failure of moral leadership.